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Brief Title: Induction Chemotherapy for Locally Recurrent Rectal Cancer
Official Title: Multicentre, Open-label, Randomised, Controlled, Parallel Arms Clinical Trial of Induction Chemotherapy Followed by Chemoradiotherapy Versus Chemoradiotherapy Alone as Neoadjuvant Treatment for Locally Recurrent Rectal Cancer - PelvEx II
Study ID: NCT04389086
Brief Summary: This is a multicentre, open-label, parallel arms, phase IIII study that randomises patients with locally recurrent rectal cancer in a 1:1 ratio to receive either induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm)
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UZ Gent, Gent, , Belgium
Amsterdam UMC, Amsterdam, , Netherlands
Antoni van Leeuwenhoek, Amsterdam, , Netherlands
Catharina Hospital, Eindhoven, , Netherlands
University Medical Centre Groningen, Groningen, , Netherlands
Leids University Medical Centre, Leiden, , Netherlands
Haaglanden Medical Centre, Leidschendam, , Netherlands
Maastricht University Medical Centre, Maastricht, , Netherlands
Erasmus Medical Centre, Rotterdam, , Netherlands
Oslo Universitetssykehus, Oslo, , Norway
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E., Lisbon, , Portugal
Sahlgrenska Universitetssjukhuset, Göteborg, , Sweden
Skåne Universitetssjukhuset, Malmö, , Sweden
Karolinska Universitetssjukhuset, Stockholm, , Sweden
Name: Pim Burger, MD
Affiliation: Catharina Ziekenhuis Eindhoven
Role: PRINCIPAL_INVESTIGATOR